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NCT03996252 · ClinicalTrials.gov registry record · Early Phase 1
Combination Topical Therapy for Treatment of Scalp Actinic Keratoses
A Early Phase 1 study, sponsored by Tulane University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
NCT03996252: Clinical Trial Early Phase 1 study, sponsored by Tulane University.
NCT03996252 is a Early Phase 1 study that was terminated before completion, run by Tulane University. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03996252, a Early Phase 1 study, was terminated before completion, sponsored by Tulane University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The aim of this study is to determine the effectiveness of combination calcipotriene 0.005% foam and 5% fluorouracil cream for the treatment of actinic keratoses on the scalp. The data obtained will be compared with the current standard of care, monotherapy with 5% fluorouracil cream. A recent randomized, double-blind clinical trial (NCT02019355) compared 0.005% calcipotriol ointment and fluorouracil 5% cream with Vaseline plus fluorouracil 5% cream for a 4-day treatment of actinic keratoses on the face, scalp and upper extremities. They found that calcipotriol plus 5-FU versus Vaseline plus fluorouracil 5% cream led to an 87.8% versus 26.3% mean reduction in the mean number of actinic keratoses. Our study will independently assess the effectiveness of combination treatment (calcipotriene 0.005% foam and fluorouracil 5% cream) on scalp actinic keratoses in a case series of up to 15 eligible participants. Participants will complete a 4-night application of combination treatment with follow-up immediately after and 8 weeks later.
Primary Outcome
Determine the efficacy of calcipotriene 0.005% foam and 5-fluorouracil 5% cream for the treatment of scalp actinic keratoses following 4 nights of combination treatment. The outcome of interest is percentage change from baseline number of actinic keratoses in the target treatment area on scalp at 8 weeks after treatment.
Interventions
- DRUG Calcipotriene 0.005% Foam
- DRUG Efudex 5% Topical Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2020-06-08 |
| Phase | Early Phase 1 |
Why NCT03996252 stopped before completion
NCT03996252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Calcipotriene 0.005% Foam is the first listed.
NCT03996252 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03996252 about?
NCT03996252 is a clinical study titled "Combination Topical Therapy for Treatment of Scalp Actinic Keratoses". The aim of this study is to determine the effectiveness of combination calcipotriene 0.005% foam and 5% fluorouracil cream for the treatment of actinic keratoses on the scalp. The data obtained will be compared with the current standard of care, monotherapy with 5% fluorouracil cream. A recent rando...
What is the current status of trial NCT03996252?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2019-07-01. Estimated completion is 2020-06-08.
What interventions are being tested in trial NCT03996252?
The interventions under investigation include: Calcipotriene 0.005% Foam (DRUG), Efudex 5% Topical Cream (DRUG).
Who is sponsoring clinical trial NCT03996252?
This trial is sponsored by Tulane University, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03996252's enrollment target sits among peer trials
15 1403rd of 2000 higher than 527 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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